References
- Pritchard-Jones K, Kaatsch P, Steliarova-Foucher E, Stiller CA, Coebergh JW. Cancer in children and adolescents in Europe: developments over 20 years and future challenges. Eur. J. Cancer 42(13), 2183–2190 (2006).
- Vassal G. Will children with cancer benefit from the new European Paediatric Medicines Regulation? Eur. J. Cancer 45(9), 1535–1546 (2009).
- Smith MA, Seibel NL, Altekruse SF et al. Outcomes for children and adolescents with cancer: challenges for the twenty-first century. J. Clin. Oncol. 28(15), 2625–2634 (2010).
Websites
- International Conference on Harmonization. Guideline on the clinical development of medicinal products with the pediatric population (E11). www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/Step4/E11_Guideline.pdf (Accessed 5 June 2012)
- FDA website. Pediatric legislation. www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049867.htm (Accessed 5 June 2012)
- EMA website. Medicines for children. www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000023.jsp&mid=WC0b01ac05800240cd (Accessed 5 June 2012)
- Regulation of the European Parliament and of the Council on medicinal products for paediatric use. Regulation (EC) No 1901/2006. http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf (Accessed 5 June 2012)
- Class waivers agreed by the Paediatric Committee. www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000036.jsp&mid=WC0b01ac05801177cd (Accessed 5 June 2012)
- Nycomed versus European Medicines Agency. Case T-52/09 Court of Justice of the European Union. http://curia.europa.eu/juris/document/document.jsf?text=&docid=116583&pageIndex=0&doclang=en&mode=doc&dir=&occ=first&part=1&cid=2726821 (Accessed 5 June 2012)